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NCT05891275 Clinical Trial

Patients With Geographic Atrophy and Their Patient Journey in the United States (US)

Geographic Atrophy Clinical Trial

Official title:
Characterization of Patients With Geographic Atrophy (GA) in the US

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05891275
Other study ID # 1484-0014
Secondary ID
Status Completed
Phase
First received
Last updated
Start date May 31, 2023
Est. completion date December 1, 2023

Study information
Verified date February 2024
Source Boehringer Ingelheim
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

To quantify and describe patients with a Geographic Atrophy (GA) diagnosis in at least one eye, and the progression to neovascular Age-Related Macular Degeneration (including how many receive Anti-VEGF), or to GA (in the fellow eye only).

Recruitment information / eligibility
Status Completed
Enrollment 68563
Est. completion date December 1, 2023
Est. primary completion date December 1, 2023
Accepts healthy volunteers No
Gender All
Age group 50 Years and older
Eligibility Inclusion Criteria: - All patients =50 years, with a GA diagnosis in at least one eye, included in the Vestrum database identified during the study period (January 2015 to April 2023). Exclusion Criteria: - Patients without the information of laterality will be excluded.

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
United States CorEvitas HQ Waltham Massachusetts

Sponsors (1)
Lead Sponsor Collaborator
Boehringer Ingelheim

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Occurrence of developing of Neovascular Age-Related Macular Degeneration (wAMD) Up to the 5th year of the follow-up period.
Primary Changes in the Geographic Atrophy (GA) lesion location Up to the 5th year of the follow-up period.
Primary Changes in the Visual Acuity (VA) Up to the 5th year of the follow-up period.
Primary Changes in the size of the GA lesion Up to the 5th year of the follow-up period.
Primary Occurrence of developing of GA Up to the 5th year of the follow-up period.
Primary Occurrence of patients with a newly diagnosis of GA Up to the 5th year of the follow-up period.
Primary Prevalence of GA Up to the 5th year of the follow-up period.
Secondary Retinal Disease Related health care resource utilization ((HCRU) Outcome:Occurrence of patients visits Up to the 5th year of the follow-up period.
Secondary Retinal Disease Related HCRU Outcomes: Occurrence of medical procedures Medical procedures include for example, checkups, cataracts removal, eye lid (ptosis correction), etc. Up to the 5th year of the follow-up period.
Secondary Occurrence of ocular comorbidities Up to the 5th year of the follow-up period.
See also
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Active, not recruiting NCT05536297 - Avacincaptad Pegol Open-Label Extension for Patients With Geographic Atrophy Phase 3
Completed NCT02515942 - CLG561 Proof-of-Concept Study as a Monotherapy and in Combination With LFG316 in Subjects With Geographic Atrophy (GA) Phase 2
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Recruiting NCT04339764 - Autologous Transplantation of Induced Pluripotent Stem Cell-Derived Retinal Pigment Epithelium for Geographic Atrophy Associated With Age-Related Macular Degeneration Phase 1/Phase 2
Completed NCT03295877 - Safety and Tolerability Study of RO7171009 in Participants With Geographic Atrophy (GA) Secondary to Age-Related Macular Degeneration (AMD) Phase 1
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Terminated NCT02247531 - A Study Investigating the Safety and Efficacy of Lampalizumab Intravitreal Injections in Participants With Geographic Atrophy Secondary to Age-Related Macular Degeneration Phase 3
Completed NCT02332343 - Sparing of the Fovea in Geographic Atrophy Progression N/A
Completed NCT01002950 - Study of the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ACU-4429 in Subjects With Geographic Atrophy Phase 2
Completed NCT03777332 - Study to Evaluate the Safety of Intravitreal APL-2 in Patients Diagnosed With Geographic Atrophy Phase 1
Active, not recruiting NCT04676854 - Restoration of Central Vision With the PRIMA System in Patients With Atrophic AMD N/A
Recruiting NCT02372916 - Geographic Atrophy and Intravitreal Ranibizumab Injections N/A
Active, not recruiting NCT05380492 - Study of VOY-101 in Patients With Advanced Non-Neovascular Age-Related Macular Degeneration Phase 1/Phase 2
Terminated NCT04607148 - A Study Assessing the Long-Term Safety and Tolerability of Galegenimab (FHTR2163) in Participants With Geographic Atrophy Secondary to Age-Related Macular Degeneration Phase 2
Terminated NCT02087085 - A Safety and Efficacy Study of Brimonidine Intravitreal Implant in Geographic Atrophy Secondary to Age-related Macular Degeneration Phase 2

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